Sunday, July 29, 2012

Novartis begins shipment of Fluvirin® seasonal influenza vaccine in US for 2012-2013 influenza season

/PRNewswire/ -- Novartis announced today that the Company has commenced shipment of its seasonal influenza vaccine to customers in the US for the 2012-2013 influenza season. The early arrival of seasonal influenza vaccines will ensure healthcare professionals are equipped to provide the earliest possible protection against influenza. This year, Novartis plans to ship more than 30 million doses of the vaccine, which has been reformulated to include two new influenza strains to meet the updated World Health Organization and US Food and Drug Administration (FDA) recommendations. Fluvirin® has been approved by FDA for persons 4 years of age and older2.

During each season, influenza may cause thousands of influenza-associated deaths and hospitalizations3,4. Federal health officials advise that the single best way to protect against influenza is to get vaccinated every year. Immunity to influenza viruses declines over time and may be too low to provide protection after one year5.

"We are continuing our dedication to meet customer demand by ensuring adequate supply of Fluvirin," said Brent MacGregor, President of US Vaccines and Head of Region North America. "The influenza vaccine will arrive in time to help meet a significant public health need and allow healthcare professionals to start administering vaccines in the lead up to the influenza season."

The Centers for Disease Control and Prevention (CDC) recommends routine seasonal influenza vaccination for all individuals 6 months of age and older. In addition, CDC advises that it is especially important for certain high-risk groups - seniors, children under the age of five, people with chronic illnesses such as asthma, diabetes or chronic lung disease and healthcare workers, as well as people who live with or care for high-risk individuals, to receive an influenza vaccine each influenza season1.

About Seasonal Influenza

Seasonal influenza is a highly communicable, acute viral infection that predominantly attacks the respiratory tract and sometimes the lungs. It can cause mild to severe illness and can also lead to death3.

The number of people in the US who die every year from influenza and its complications could be comparable to the more than 41,500 people in the US who die each year from breast cancer, and to about half of the estimated 73,000 people who die annually of diabetes and its complications each year in the US6,7.

Influenza vaccination is one of the most effective public health interventions ever implemented, sparing millions of people from complications, including death, from this infectious disease. Use of currently available seasonal influenza vaccines has been calculated to save more than 8 million lives annually worldwide, translating to one person saved every five seconds8.

About Fluvirin

Fluvirin vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine2.

For the 2012-2013 season, Fluvirin contains antigens that target three influenza virus strains identified by World Health Organization (WHO) experts as likely to dominate circulation. These include:

  • A/California/7/2009 (H1N1)-like virus
  • A/Victoria/361/2011 (H3N2)-like virus
  • B/Wisconsin/1/2010-like virus (from the B/Yamagata lineage of viruses)

Important Safety Information

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From another article:
(Dated 2/28/12) background on vaccine choice:

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on Feb. 28 recommended that the vaccine for the next influenza season should include two new strains and retain only one of the three strains in the current vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 18-0 that the 2012-2013 seasonal flu vaccine used in the United States should include the same influenza A (H1N1) component included in the 2011-2012 vaccine, an A/California/7/2009 (H1N1)-like virus. For the second influenza A strain in the vaccine, the panel’s vote was also unanimous, recommending that the influenza A (H3N2) component be replaced with an A/Victoria/361/2011 (H3N2)-like virus.

The panel voted 17-1 that that the influenza B strain be replaced with a B/Wisconsin/1/2010-like virus (B/Yamagata lineage). The current vaccine strain is a B/Brisbane/60/2008-like virus, a B/Victoria lineage strain. Panelists pointed out, however, that determining which B strain to select, a Victoria or Yamagata lineage B strain virus, is always challenging and said that this illustrated the utility of a quadrivalent influenza vaccine that contains B/Victoria lineage and B/Yamagata lineage viruses.

It appears that a quadrivalent influenza vaccine may soon be available, possibly as early as 2013. At the meeting, representatives of several vaccine manufacturers provided updates on the status of their quadrivalent influenza vaccines in development, including GlaxoSmithKline, which has filed for FDA approval of a quadrivalent influenza vaccine for people aged 3 and older.

The FDA panel’s recommendations are the same as the World Health Organization’s recommendations for the 2012-2013 Northern Hemisphere seasonal influenza vaccine, made at a meeting earlier in February.

The FDA panel meets at this time every year to recommend the strains to be included in the trivalent influenza vaccine in the United States in the upcoming season, considering information on the strains circulating worldwide and the WHO recommendation for the vaccine to be used in the Northern Hemisphere.

This influenza season has started late, in February, and flu activity has been low, although it is expected to increase, the Centers for Disease Control and Prevention announced last week.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

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